EPIPEN - EPIPEN - CT 6662 - English version

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Introduction EPIPEN 0.15 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 033-2) B/2, blister strips (PP/Alu) (CIP code: 388 034-9) EPIPEN 0.30 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 030-3) B/2, blister strips (PP/Alu) (CIP code: 388 032-6) Posted on Jun 04 2012 Active substance (DCI) adrenaline URGENCES - NOUVEAU MEDICAMENT Pas d’avantage clinique démontré par rapport à ANAPEN dans le traitement du choc anaphylactique EPIPEN est une seringue pré-remplie d’adrénaline dans un dispositif d’auto-injection pour usage intramusculaire, disponible en deux dosages : 0,15 mg/0,3 ml et 0,30 mg/0,3 ml.Il est indiqué dans le traitement d’urgence des symptômes du choc anaphylactique.EPIPEN est la deuxième spécialité d’adrénaline auto-injectable pouvant être conservée à température ambiante et administrée dès les signes précurseurs et les premiers symptômes du choc anaphylactique.Il n’a pas démontré d’avantage clinique ni technique supplémentaire par rapport à ANAPEN.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code C01CA24 Laboratory / Manufacturer MYLAN EPIPEN 0.15 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 033-2) B/2, blister strips (PP/Alu) (CIP code: 388 034-9) EPIPEN 0.30 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 030-3) B/2, blister strips (PP/Alu) (CIP code: 388 032-6) Posted on Jun 04 2012

Sujets

• Pédiatrie
• Allergie

Informations

• Publié par: haute-autorite-sante-maladies-systeme-immunitaire
• Publié le: 27 mai 2009
• Nombre de lectures: 18
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

   

 

  The legally binding text is the original French version

TRANSPARENCY COMMITTEE   OPINION   27 May 2009     EPIPEN 0.15 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 033-2) B/2, blister strips (PP/Alu) (CIP code: 388 034-9)   EPIPEN 0.30 mg/0.3 mL, solution for injection in prefilled syringe (Auto-lnjector) B/1, blister strips (PP/Alu) (CIP code: 388 030-3) B/2, blister strips (PP/Alu) (CIP code: 388 032-6)     Applicant: MYLAN   Adrenaline    List I   ATC code: C01CA24   Date of Marketing Authorisation (national procedure): 3 September 2008.     Reason for request: Inclusion on the list of drugs reimbursed by National Health Insurance and approved for hospital use.                                   Medical, Economic and Public Health Assessment Division  

 

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"EPIPEN should only be injected intramuscularly into the anterolateral aspect of the thigh, and not into the buttock. The injection area may be massaged gently for 10 seconds after administration. EPIPEN 0.15 mg/0.3 mL or 0.30 mg/0.3 mL Auto-Injectors are intended for immediate self-administration by individuals with a history of anaphylactic reaction. They are designed to deliver a single 150 or 300 dose of adrenaline. For reasons of mL)g (0.3 stability, an unused volume of 1.7 mL remains in the syringe after use. However, the device should not be reused and should be disposed of, taking the appropriate safety precautions.   The usual effective dose is between 0.005 and 0.01 mg/kg, but higher doses may be needed in some circumstances.   Use in children The appropriate dose is 150 or 300 mg/0.3 mL)g (EPIPEN 0.15g (EPIPEN 0.30 mg/0.3 mL) of adrenaline depending on the child's body weight and the doctor's decision. A further injection may be required in children with a high bodyweight.   The product should not be used in children weighing under 15 kg except in a life-threatening situation or at the doctor's decision, as doses below 150g adrenaline cannot be administered accurately to these children.   Use in adults The usual dose is 300g. A further injection may be required in patients with a high body weight.   In some situations, a single dose of adrenaline may not be sufficient to reverse the effects of an acute allergic reaction. In this case, a further dose may be injected after 10-15 minutes.     The patient must have two syringes. EPIPEN comes in packs of two auto-injectors".  

1.3.

"Emergency treatment of allergic reactions (anaphylaxis) to insect stings or bites, peanuts or other foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis". 

Dosage

Indication

1.2.

1.1.

Adrenaline 

 

Active ingredient

 

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CHARACTERISTICS OF THE MEDICINAL PRODUCT

2.1.

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SIMILAR MEDICINAL PRODUCTS

ATC Classification (2008)

C C01 : C01C : C01CA : C01CA24 :

Cardiovascular system Cardiac therapy Cardiac stimulants excluding cardiac glycosides Adrenergic and dopaminergic agents Epinephrine 

2.2. Medicinal products in the same therapeutic category

Devices containing adrenaline for self-injection: In adults and children weighing more than 15 kg (about 4 years): - ANAPEN, solution for IM injection 1   Two dosages: 0.15 mg/0.3 mL and 0.30 mg/0.3 mL   In adults and children aged over 6 years: - ANAHELP 1 mg/1 mL, solution for SC or IM injection 2    

3 ANALYSIS OF AVAILABLE DATA  

3.1. Efficacy No clinical trials of efficacy and/or safety are available which have compared EPIPEN to other preparations containing adrenaline.   Comparison of EPIPEN with other available medicinal products is therefore limited to analysis of their technical characteristics (particularly with regard to the auto-injector).   3.2. Adverse effects Adverse effects depend on the patient's sensitivity and the dose administered. The anticipated safety profile of EPIPEN is comparable to that of other preparations containing adrenaline:  At low dose, the common adverse effects are: palpitations, tachycardia, sweating, nausea, vomiting, respiratory difficulty, pallor, dizziness, weakness, tremor, headache, apprehension, nervousness and anxiety.   At high dose or in patients sensitive to adrenaline, the adverse effects are: arrhythmia (ventricular fibrillation/cardiac arrest), sudden rise in blood pressure (occasionally causing brain haemorrhage), or even vasoconstriction (e.g. in the skin, mucosa or kidneys).   EPIPEN and ANAPEN contain sodium metabisulfite and may cause allergic reactions which may include anaphylactic symptoms, or may even be life-threatening. Mild asthma may also occur in some patients who are sensitive to sulfite.

                                             1  ANAPEN pens come as prefilled syringes inside an auto-injector device and may be stored at ambient temperature (not exceeding + 25°C) in the original primary pack to protect the medicinal product from light.   2 ANAHELP comes in the form of an emergency kit for prevention and treatment of anaphylactic shock: - 1 sterile syringe for self-injection - 1 four-position piston for delivery of 0.25 mL, 0.50 mL, 0.75 mL or 1 mL, depending on the number of tabs broken (the piston cannot be used unless screwed onto the black tip contained in the syringe). ANAHELP should be  at ambient temperaturestored between +2°C and +8°C and can be c arried 2 .   3  

3.3. Conclusion EPIPEN is the second medicinal product to be introduced on the market in the form of a prefilled syringe of adrenaline in an auto-injector device for intramuscular use, for the treatment of anaphylactic shock. The data supplied do not demonstrate any additional clinical benefit of EPIPEN compared with other preparations of adrenaline for self-injection.   ANAPEN and EPIPEN have different self-injection devices.    

4 TRANSPARENCY COMMITTEE CONCLUSIONS

4.1. Actual benefit

Anaphylactic shock is a life-threatening condition. EPIPEN is a first-line curative therapy   with a substantial efficacy/adverse effects ratio. For children aged 4-6 years there is only one alternative therapy, i.e. ANAPEN.   Public health benefit It is not possible to assess the burden resulting from anaphylactic shock, in view of the absence of predisposing factors and the wide variation in individual reactions to possible allergens. Treatment of anaphylactic shock and prevention of its consequences is a public health need. In the event of anaphylactic shock, intramuscular self-injection of adrenaline has a major impact on morbidity and mortality and reduces the use of emergency care services. EPIPEN has no additional impact compared with the adrenaline auto-injectors already on the market. EPIPEN is therefore a new alternative treatment option. Consequently, no public health benefit is anticipated for the medicinal product EPIPEN.   The actual clinical benefit of EPIPEN is substantial.   4.2. Improvement in actual benefit (IAB)

EPIPEN does not provide any improvement in actual benefit (IAB level V) over ANAPEN. EPIPEN is a useful additional form of treatment.

4.3. Therapeutic use

Treatment of anaphylactic shock is a clinical emergency. Treatment may require admission to hospital in the intensive care unit for appropriate resuscitation measures. Adrenaline is a sympathomimetic amine; it is a catecholamine secreted naturally by the adrenal glands in response to exhaustion or stress. It is the drug of choice 3  treating for allergic or idiopathic hypersensitivity reactions and exercise-induced anaphylaxis. One of the characteristics of anaphylactic shock is its rapid reversibility if treatment is started early and at the right doses. Anyone with a history of anaphylactic shock or a high degree of risk because of an atopic condition should benefit from an adrenaline auto-injector system.

                                             3   Adrenaline has a vasoconstrictrive action induced by major stimulation of alpha-adrenergic receptors. This allows it to control vasodilatation and excessive vascular permeability which lead to loss of intravascular fluid and hypotension, the predominant pharmacotoxic symptoms responsible for anaphylactic shock. The stimulant action of adrenaline on beta-adrenergic bronchial receptors leads to powerful bronchodilatation which reduces respiratory wheeze and dyspnoea. Adrenaline also alleviates pruritus, urticaria and angioedema associated with anaphylaxis (SPC) . 4  

EPIPEN 0.15 mg/0.3 mL or 0.30 mg/0.3 mL Auto-Injectors are intended for immediate self- administration by individuals with a history of anaphylactic reaction. The Auto-Injector is designed to deliver a single dose. An EPIPEN injection should be performed into the muscle, without delay, as soon as precursor signs and symptoms of anaphylactic shock appear. These signs and symptoms may occur within a few minutes of exposure to the allergen. They usually manifest as urticaria, hot flushes or angioedema. More severe reactions may affect circulatory and pulmonary systems. In some situations, a single dose of adrenaline may not be sufficient to reverse the effects of an acute allergic reaction. In this case, a further dose may be injected after 10-15 minutes. The patient must therefore have two syringes. EPIPEN is a useful additional form of treatment (having   a second Auto-injector also helps to reduce the risk of disruption of supplies of these emergency drugs).

4.4. Target population

The target population for EPIPEN is defined as patients with a history of anaphylactic shock or a high degree of risk because of an atopic condition.   Quantitative estimate:   The target population has been increasing for the last 10 years or so; its size may be estimated approximately on the basis of the following hypotheses: - The great majority of allergies that may require adrenaline are food allergies and hymenoptera stings (reason given in more than 95% ATU requests for ANAPEN). - The prevalence of food allergy is between 2.1% and 3.8% of the general population (AFSSA document, January 2002). 10%-20% of these individuals develop a severe form requiring them to keep an adrenaline auto-injector with them at all times. - The prevalence of allergy to hymenoptera stings is about 1% in the general population. The proportion of this population that may develop a severe form is not known with any accuracy (a hypothetical figure is between 10% and 20%). - Individuals with a history of anaphylactic shock are included in the population defined above.   On the basis of these observations, the estimated target population is between 180 000 and 580 000 individuals.

4.5. Transparency Committee recommendations

The Transparency Committee recommends inclusion on the list of medicines reimbursed by National Health Insurance and on the list of medicines approved for use by hospitals and various public services in the indications and at the dosage given in the Marketing Authorisation.    Packaging: The packaging is appropriate for the prescription conditions given in the Marketing Authorisation. The patient should carry two syringes. A pack of two Auto-Injectors is available.   Reimbursement level: 65%  

 

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